drugset / Trial / NCT07562711

Randomized Study of Plasma ctDNA Methylation to Guide Adjuvant Chemotherapy Decisions in High-Risk T3N0 Colorectal Cancer

NCT07562711 ↗

Phase 2 Recruiting 340 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will utilize ctDNA methylation detection to evaluate patients with high-risk T3N0 stage II colorectal cancer who are ctDNA-positive one month after surgery. It aims to investigate the impact of different adjuvant chemotherapy regimens on ctDNA clearance rates and their prognostic significance. By using postoperative ctDNA status to identify patients at high risk of recurrence, the study seeks to implement intensified chemotherapy strategies (treatment escalation) at an early stage, thereby improving ctDNA clearance and ultimately enhancing patient outcomes

Timeline

Start
2024-11-01
Primary completion
2027-12-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule — —
Subject Oxaliplatin Small molecule — —
Subject fluorouracil Small molecule — —
Background Leucovorin Small molecule — —

Indications